Skip to main content
MedPath Trial logoMedPath TrialMedPath Trial Home
Clinical Trials/NCT05712161
NCT05712161Active, not recruitingNot Applicable

Use of DurAVR™ THV System in Subjects With Severe Aortic Stenosis: Early Feasibility Study

Anteris Technologies Ltd.6 sites in 1 country15 target enrollmentStarted: August 7, 2023Last updated:
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Active, not recruiting
Enrollment
15
Locations
6
Primary Endpoint
Technical success
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

To evaluate the safety and feasibility of DurAVR™ THV System in the treatment of subjects with symptomatic severe native aortic stenosis.

Detailed Description

The primary objective is to assess the acute and long-term safety and feasibility of the DurAVR™ device in adult subjects with symptomatic, severe native aortic stenosis eligible for the transcatheter aortic valve replacement as assessed by the Heart Team at the enrolling institutions.

This is a prospective, non-randomized, single-arm, multi-center Study. Subjects will be consented for follow-up to 10 years.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Device Feasibility
Masking
None

Eligibility Criteria

Ages
65 Years to — (Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Subjects are eligible for entry in this study if ALL the following conditions are met:
  • •Symptomatic, severe native aortic stenosis in subjects 65 years or older
  • •Requires aortic valve replacement and is indicated for TAVR as determined by the Heart Team (composed of an experienced interventional cardiologist and an experienced cardiac surgeon)
  • •Eligible for transfemoral delivery of the DurAVR™ THV
  • •Anatomy appropriate to accommodate safe placement of DurAVR™ THV (Preprocedural measurements by TTE and CT required: aortic annulus diameter 21-23 mm by CT)
  • •Understands the study requirements and the treatment procedures and provides written informed consent
  • •Subject agrees to complete all required scheduled follow-up visits.

Exclusion Criteria

  • •Subjects are eligible for entry in this study if NONE of the following conditions are met:
  • •Anatomy precluding safe placement of DurAVR™ THV
  • •Pre-existing prosthetic heart valve in any position
  • •Unicuspid or bicuspid aortic valve
  • •Severe aortic regurgitation
  • •Severe mitral or severe tricuspid regurgitation requiring intervention.
  • •Moderate to severe mitral stenosis.
  • •Hypertrophic obstructive cardiomyopathy
  • •Echocardiographic evidence of intracardiac mass, thrombus or vegetation requiring treatment.
  • •Severe basal septal hypertrophy with outflow gradient
  • •Evidence of an acute myocardial infarction ≤ 30 days before the intended treatment.
  • •Determined inoperable/ineligible for surgery by the Heart Team
  • •Any percutaneous coronary or peripheral interventional procedure performed within 30 days prior to the index procedure
  • •Blood dyscrasias as defined: leukopenia (WBC < 1000 mm3), thrombocytopenia (platelet count < 50,000 cells/mm3), history of bleeding diathesis or coagulopathy, or hypercoagulable states
  • •Untreated clinically significant Coronary Artery Disease (CAD) requiring revascularization
  • •Cardiogenic shock manifested by low cardiac output, vasopressor dependence, or mechanical hemodynamic support
  • •Need for emergency surgery for any reason
  • •Ventricular dysfunction with left ventricular ejection fraction (LVEF) < 30% as measured by resting echocardiogram
  • •Recent (within 6 months) cerebrovascular accident (CVA) or transient ischemic attack (TIA).
  • •Symptomatic carotid or vertebral artery disease
  • •End stage renal disease requiring chronic dialysis or creatinine clearance < 20 cc/min.
  • •GI bleeding within the past 3 months
  • •A known hypersensitivity or contraindication to any of the following which cannot be adequately pre-medicated: aspirin, heparin, nitinol (titanium or nickel), ticlopidine and clopidogrel, contrast media
  • •Ongoing sepsis, including active endocarditis (Duke Criteria) [49]
  • •Subject refuses a blood transfusion
  • •Life expectancy < 12 months due to associated non-cardiac co-morbid conditions
  • •Other medical, social, or psychological conditions that in the opinion of an Investigator precludes the subject from appropriate consent
  • •Severe dementia (resulting in either inability to provide informed consent for the trial/procedure, prevents independent lifestyle outside of a chronic care facility, or will fundamentally complicate rehabilitation from the procedure or compliance with follow-up visits)
  • •Currently participating in an investigational drug or another investigational device trial
  • •Subject is contraindicated for MDCT or MRI Scans.
  • •Subject belongs to a vulnerable population (Vulnerable subject populations are defined as individuals with mental disability, persons in nursing homes, children, impoverished persons, homeless persons, nomads, refugees, and those permanently incapable of giving informed consent. Vulnerable populations also may include members of a group with a hierarchical structure such as university students, subordinate hospital and laboratory personnel, employees of the Sponsor, members of the armed forces, and persons kept in detention).

Arms & Interventions

DurAVR™ THV System

Experimental

TAVR procedure

Intervention: DurAVRTM THV System (Device)

Outcomes

Primary Outcomes

Technical success

Time Frame: Immediate post procedure

Freedom from mortality, successful device implant, and freedom from surgery or intervention related to the device.

All-cause mortality or disabling stroke

Time Frame: 30days

Mortality would be reported as rate of death/mortality at 30 days. Disabling stroke would be reported according to VARC-3 Guidelines

Secondary Outcomes

  • Major vascular, access-related, or cardiac structural complication(30days)
  • All-cause mortality(30days)
  • VARC-3 Type 2-4 bleeding(30days)
  • Acute Kidney Injury stage 3 or 4(30days)
  • Moderate or severe aortic regurgitation(30days)
  • New permanent pacemaker due to procedure related conduction abnormalities(30days)
  • Disabling stroke(30days)
  • Surgery or intervention related to the device, including aortic valve reintervention.(30days)

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (6)

Loading locations...

Similar Trials

Active, not recruiting
Not Applicable
DurAVR™ THV System: EMBARK StudySymptomatic Aortic StenosisSevere Aortic Valve StenosisAortic Valve Calcification
NCT05182307Anteris Technologies Ltd.150
Active, not recruiting
Not Applicable
DurAVR™ THV EU-EFSAortic Valve FailureSymptomatic Aortic StenosisSevere Aortic Valve StenosisAortic Valve CalcificationAortic Valve Disease
NCT06510855Anteris Technologies Ltd.15
Completed
Phase 3
Clinical Study to Assess the Efficacy and Safety of THVD-201 in Patients With OABOveractive Bladder
NCT02485067SK Chemicals Co., Ltd.384
Unknown
Phase 4
Treatment of Primary CNS LymphomaPrimary CNS Lymphoma (PCNSL)
NCT01960192Mingzhi Zhang50
Completed
Not Applicable
Pulsta® Transcatheter Pulmonary Valve Korean Multicenter StudyPulmonary Valve StenosisCongenital Heart DefectPulmonary Valve Insufficiency, Congenital
NCT03110861Taewoong Medical Co., Ltd.15